Shoulder Implant Extraction Set Elbow Hand & Wrist Hip Pelvis Femur Tibia & Fibula Foot & Ankle Implant Extraction Guide Module One & Two Contents Precautions and Contraindications 3 Product Description 4 Screws 6 Condyle Screws6 Cannulated Screws 7 Damaged Screw Head 7 Broken Screws 8 Plates 9 Broken Cannulated Screws 10 Lag Screw 11 Intramedullary Nails 13 Broken Intramedullary Nails 14 This publication sets forth detailed recommended procedures for using Stryker devices and instruments. It offers guidance that you should heed, but, as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required. A workshop training is recommended prior to first surgery. See package insert (L22000007) for a complete list of potential adverse effects, contraindications, warnings and precautions. The surgeon must discuss all relevant risks, including the finite lifetime of the device, with the patient, when necessary. 2 Precautions and Contraindications Precautions Stryker systems have not been evaluated for safety and compatibility in MR environment and have not been tested for heating or migration in the MR environment, unless specified otherwise in the product labeling. Contraindications Cold welded screws require cutting tools for metal to remove the screws. The extraction set does not feature carbide drills or other cutting tools to remove cold welded screws. Stryker can only recommend use of the extractor instruments with its own products. Application of the instruments to competitive products or to Stryker products that have been altered may be possible but has not been validated. Where competitive products are mentioned in this document this is solely to indicate where application of the extractor instruments appears possible due to similar design or dimensions, and Stryker does not guarantee that the extractor instruments demonstrated herein will work in any cases where competitive products are used, or in cases where Stryker products have been altered. As a precaution, make sure to have other standard instruments available in case the tolerances of the implants do not match the tolerances of the extractor tool. 3 Product Description Instrument Stryker Systems Teardrop Handle (AO-Medium) Screwdriver Bit 2.5mm (conical) Screwdriver Bit 3.5mm (conical) Screwdriver Bit 4mm (conical) Screwdriver Bit 5mm Screwdriver Bit 6.3mm Screwdriver Bit 8mm Screwdriver Bit T 8 (Torx) Screwdriver Bit T 15 (Torx) Screwdriver Bit T 20 (Torx) Screwdriver Bit T 25 (Torx) Conical Extractor, male, left hand, small (left hand driving) for diameter range 1–2.5mm Conical Extractor, male, left hand, 2.5mm (left hand driving, for damaged hex 2.5mm and diameter range 2.3–4mm) Conical Extractor, male, left hand, 3.5mm (left hand driving, for damaged hex 3.5mm and diameter range 3.3–4mm) Conical Extractor, male, left hand, 4mm (left hand driving, for damaged hex 4mm and diameter range 3.8–4.4mm) Conical Extractor, male, left hand, 5mm (left hand driving, for damaged hex 5mm and diameter range 4.8–5.4mm) Crown drill 3 (bone drill for broken screws with diameter range ≤ 3mm Crown drill 4 (bone drill for broken screws with diameter range ≤ 4mm 4 For AO-medium bits: - Screwdriver bits - Crown drills (Trephines) - Conical extractors male/female Screws: - T2 humeral compression - AsnisIII 4.0mm - Numelock 4.5mm - ISO 2.7mm - ISO 3.5mm - ISO 4.0mm Screws: - 4mm and 5mm locking screws (T2, S2, Gamma3, IC etc.) - T2/S2 end caps - T2/S2 femur/tibia compression screws - TLN all screws - 3.7mm and 4.6mm locking screws Grosse & Kempf - AsnisIII 5.0mm - Numelock 6.5mm - ISO 4.5mm - ISO 6.5mm Screws: - Set Screw for Gamma, Gamma3, Gamma Ti, Dyax-A, AP, AP-J; - Proximal Plug for Gamma, Gamma Ti, Dyax, Dyax-A, AP, AP-J Screws: - 6.28mm locking screws - AsnisIII 6.5mm and 8.0mm - T2, S2, Recon lag screws Screws: - T2, S2 condyle screws Screws: - Grosse & Kempf, SCN condyle screws - Gamma3 end cap Screws: - AxSOS 3.0mm Screws: - AxSOS 4.0mm Screws: - Alta 3.7mm locking screws - AxSOS 5.0mm Screws: - Alta 5mm locking screws, lag screws and caps Screws: - AsnisIII 4.0mm Screws: - T2 Humerus compression - AsnisIII 4.0mm - ISO 2.7mm - ISO 3.5mm - ISO 4.0mm Screws: - 4mm and 5mm locking screws (T2, S2, Gamma3, IC etc.) - T2, S2 end caps - T2, S2 femur/tibia compression screws - TLN all screws - 3.7mm and 4.6mm locking screws Grosse & Kempf - AsnisIII 5.0mm - ISO 4.5mm - ISO 6.5mm Screws: - Set Screw for Gamma, Gamma3, Gamma Ti, Dyax-A, AP, AP-J; - Proximal Plug for Gamma, Gamma Ti, Dyax, Dyax-A, AP, AP-J Screws: - 6.28mm locking screws - AsnisIII 6.5mm and 8.0mm - T2, S2 Recon lag screws n/a n/a Product Description Instrument Crown drill 5 (bone drill for broken screws with diameter range ≤ 5mm Crown drill 6.5 (bone drill for broken screws with diameter range ≤ 6.5mm Crown drill 8 (bone drill for broken screws with diameter range ≤ 8mm Crown drill 10 (bone drill for broken screws with diameter range ≤ 10mm Crown drill 12 (bone drill for broken screws with diameter range ≤ 12mm Conical Extractor, female, left hand, 3 (left hand driving, for broken screws with diameter range ≤ 3mm) Conical Extractor, female, left hand, 4 (left hand driving, for broken screws with diameter range ≤ 4mm) Conical Extractor, female, left hand, 5 (left hand driving, for broken screws with diameter range ≤ 5mm) Conical Extractor, female, left hand, 6.3 (left hand driving, for broken screws with diameter range ≤ 6.3mm) Teardrop Handle, AO-Medium, cannulated (including rotation rod) Spreading Screwdriver Bit 5mm Spreading Screwdriver Bit 6.3mm Spreading Screwdriver Bit 8mm Punches 2.7mm Punches 3.7mm Punches 5mm Forceps, (small) Forceps, (large) Conical Extraction Rod 6mm Conical Extraction Rod 8mm Conical Extraction Rod 10mm Conical Extraction Rod 13mm Extraction Hook, (small) Extraction Hook, (large) Extraction Instrument Lag Screw Nut Threaded Rod M7 Threaded Rod M5 Threaded Rod M4 Spanner SW17 Connector, Gamma Connector, Gamma U-Blade Connector, Gamma3 U-Blade Connector, Dyax Connector, Gamma3 Connector, Omega and Omega Plus Connector, OHS/OCS Stryker Systems n/a n/a n/a n/a n/a - ISO 2.7mm screws, Ulna locking screws - T2, S2 4mm locking screws, Grosse & Kempf 3.7mm locking screws - ISO screws - 3.5mm and 4.0mm, Alta 3.7mm locking screws - 5mm locking screws (T2, S2, Gamma3, IC, Alta etc.) - ISO screws 4.5 - 6.28mm locking screws For AO-medium bits: - Spreading screwdriver - 6.28mm locking screws - AsnisIII 6.5mm and 8.0mm - T2, S2 Recon lag screws - T2, S2 condyle screws - Grosse & Kempf, SCN condyle screws - Gamma3 end cap - For broken screws with diameter range ≤ 3mm - For broken screws with diameter range from 3–4mm - For broken screws with diameter range >4mm - For damaged screws, broken screws with diameter <9mm - For damaged screws, broken screws with diameter >9mm Extraction of nails using proximal nail end: - T2 humeral Extraction of nails using proximal nail end: - Humerus Seidel, T2 proximal humeral, T2 humeral, - Alta humeral, TLN (M7), SCN (M8), Alta femoral & tibial, Zickel, - IC femoral & tibial, T2, S2 tibial & femoral antegrade/retrograde Extraction of nails for the proximal nail end: - All G/K nails (Fem, Tib, SFN, STN, SCN) Extraction of nails using proximal nail end: - Gamma3 - Gamma, Dyax, Gamma APJ Extraction of cannulated nails with inner diameter 4.6-5.5mm: G&K, Gamma3 (Ti), Seidel, IC, SCN, TLN, T2/S2 Extraction of cannulated nails with inner diameter =>5.6mm: Gamma, Gamma3 (StSt), Dyax, Dyax-A, AP, AP-J, G&K, IC, SCN, Kuentscher Nails - Consisting of handle and extraction rod - To be used with the threaded rod and nut for the lag screw extraction - Fastens the extraction rod to the threaded rods and connectors - Threaded into lag screw (Gamma/Dyax-A), fastens connection between extraction rod and connectors - Threaded into lag screw (Omega), fastens connection between extraction rod and connectors - Threaded into lag screw (OHS/OCS), fastens connection between extraction rod and connectors - Serves for larger torque transmission of the extraction instrument lag screw - Fits onto the specific lag screws, over the threaded rod and connects with the extraction instrument lag screw Caution: Implants can be subject to change. This can impact the compatibility of extraction instruments. It is therefore required to start the implant extraction with a complete extraction set in order to have access to alternative instruments. 5 Screws Implant Extraction Set Screws After identifying screw type and diameter, extract the screws with the appropriate screwdriver bit by turning the screwdriver counterclockwise. Screws with reverse cutting flutes (e.g. AsnisIII screws, T2 Recon lag screws) can be removed using the spreading screwdriver bits and cannulated handle. Screwdriver Bits (hex) To avoid damaging the screw, make sure the screwdriver is in line with the screw axis and fully inserted. Screwdriver Bits (torx) Solid Teardrop Handle For condyle screw removal, assemble the necessary screwdrivers: The 6.3mm hex screwdriver bit with the solid teardrop handle (for the nut) and the 6.3mm hex spreading Screwdriver bit with the cannulated teardrop handle (in combination with the rotation rod) as shown in the illustration. Screwdriver Bit Solid Teardrop Handle Spreading Screwdriver Bit Teardrop Handle (cannulated) Rotation Rod 6 For spreading screwdriver instructions see condyle screw removal below. Stryker offers a wide variety of hex (standard, conical, spreading,) and torx screwdrivers. Check the available type and size on the ordering information page. Make sure to tighten the rotation rod until the tip of the screwdriver spreads firmly and fully into the screw head. A screwdriver needs to be inserted from each side of the condyle screw using one to stabilize the nut and the spreading screwdriver to loosen and extract the condyle screw. If necessary, use the spreading screwdriver to remove the nut in a second step. The condyle screw is extracted by turning the screwdriver in a counterclockwise direction. Never use a worn or damaged screwdriver to remove screws. Reverse cutting flutes are present for this reason. It is recommended that the solid screwdriver be used for screw removal. The solid screwdriver applies greater torque and may reduce the potential for damaging the hexagonal tip on the screwdriver. Strong bone formation around the implant is possible in the pediatric cases using partially threaded screws. This may lead to difficult implant removal with an increased risk of screw head breakage or stripping of screw hexagonal head. Solid Teardrop Handle Spreading Screwdriver Bit Screwdriver Bits (hex) Teardrop Handle (cannulated) Rotation Rod If the oblique direction of the screw (approximately 135° to the shaft) is not changed, then the reverse flutes are not in an optimal position to cut the cortex. If the screw head is placed under traction and the angle of the screw is brought to a perpendicular position relative to the bone, cutting the cortex will progress and facilitate screw removal. Be sure to use the solid screwdriver in combination with the appropriate sized screwdriver bits or the cannulated screwdriver with the spreading screwdriver bits. Proceed as described above. Damaged Screw Head Screw stripping is commonly caused by slippage of a screwdriver that is not correctly aligned with the screw axis and/or fully seated. This may occur either during insertion or, more commonly, during attempted screw removal. The appropriate sized conical extractor (based on the size of the screw head hex/torx) is inserted firmly into the screw head. Conical Extractor (male) Solid Teardrop Handle Forceps for Screw Removal Slotted Hammer Lightly tapping the conical extractor with a slotted hammer may be tried if purchase is not initially obtained with manual pressure. It is at the surgeon's discretion if and how hard to use the hammer. Assemble the selected conical extractor (male) with the teardrophandle and turn it counter-clockwise while applying pressure in line with the screw axis, extracting the screw at the same time. If the screw does not come completely out, the forceps can be used to complete the extraction. 7 Screws Implant Extraction Set Technical Details Screws Plates To remove any plate, first extract all screws by using the appropriate size Screwdriver Bits. Remove the plate by using a regular forceps. The development of locking plate technology has led to “cold welding” of screws to the plates. In this case, cutting tools for metal have to be used for the removal of the screws. In order to help protect the soft tissue from excessive heat and metal debris accumulation, irrigation and suction should be used in combination with cutting tools. Warning: If screws are cold welded to the plate, carbide drills may be required. The extraction set does not feature carbide drills or any other instruments to remove cold welded screws. Solid Teardrop Handle Crowndrill (Trephine) Screwdriver Bit Solid Teardrop Handle Forceps 8 Implant Extraction Set Broken Screws In case of a broken screw shaft: Step 1: Remove the screw head portion in order to gain access to the remaining part of the screw shaft. The screw head can be removed with the appropriate screwdriver as described on page 6. Step 2: Use the drift punch to extract the remaining part of the screw. If difficulties are encountered with the above process, overdrill the remaining part of the screw with a crown drill before proceeding with the drift punch. In case of a torn- off screw head: Alternatively, the optional countersink (6mm or 8mm) can be used to create a path for the crown drill. Step 1: Overdrill the remaining part of the screw with a crown drill. Use another crown drill, one size larger, in order to create space for the female conical extractor/ drift punch. It may be necessary to start with light pressure on the crown drill in order to avoid the drill walking on the cortex surface before applying additional pressure to penetrate the bone. Light tapping with the slotted hammer may be required. It remains at the surgeon's own discretion if and how hard to use the slotted hammer. Step 2: Remove the remaining part of the screw with the conical extractor, (female) if the screw is broken close to the first cortex or with the help of a drift punch if the screw is broken close to the second cortex. This procedure can also be applied to broken intramedullary nail locking screws. Screwdriver Bit Drift Punches Slotted Hammer Crown drill (Trephine) Conical Extractor (female) Forceps for Screw Removal Solid Teardrop Handle Broken screw shaft - Step 1 Broken screw shaft - Step 2 Torn-off screw head - Step 2 Torn-off screw head - Step 1 9 Screws Implant Extraction Set Broken Cannulated Screws To remove the torn-off head: If steps 1 and 2 are unsuccessful for screw removal: Step 1: Select the appropriate spreading screwdriver bit. Attach cannulated teardrop handle. Insert rotation rod through the top of the teardrop handle. Insert tip into the screw head and turn rotation rod to engage and remove screw head. To remove remaining screw body (parts): Step 3: Overdrill the shaft using the crown drill. Step 4: Use a conical extractor (female) for screw removal. Spreading Screwdriver Bit Step 2: Insert the conical extractor (male) and extract the remaining screw body turning the conical extractor in a counter-clockwise fashion. Crown drill (Trephine) If the attempt for screw removal is not successful, follow the standard procedure for broken screw removal described on page 8. Conical Extractor (male) Conical Extractor (female) Rotation Rod Teardrop Handle (cannulated) Cannulated Screw Removal - Method A - Step 1 Cannulated Screw Removal - Method A - Step 2 Cannulated Screw Removal - Method B - Step 1 Cannulated Screw Removal - Method B - Step 2 10 Lag Screw Implant Extraction Set Lag Screw Make a small incision through the old scar distal to the greater trochanter to expose the outer end of the lag screw. An incision is made over the proximal end of the nail. The end cap, if used, is removed using the appropriate screwdriver bit followed by removal of the set screw using the 4.0mm screwdriver as shown in the image below 1 . Screwdriver Bit Hex 3.5mm The threaded rod is then attached and tightened into the lateral, exposed end of the lag screw 2 . Threaded Rod For Gamma implants: position the K-wire through the lag screw. Solid Teardrop Handle The threaded rod is inserted over the K-wire (when used for Gamma) and tightened into the lateral, exposed end of the lag screw. Remove the K-wire, if used. 1 2 11 Implant Extraction Set Lag Screw (continued) Connector Threaded Rod Lag Screw Extraction Rod and Nut Wrench 8/10mm, standard Check that ingrowth does not obstruct secure engagement of the extraction device, otherwise the implant or the instrument may be damaged and extraction will be more difficult. Slide the appropriate connector over the threaded rod before adding the extraction rod & nut as shown in the picture 3 . Note: The Gamma3 lag screw was selected as an example to demonstrate lag screw removal. 3 However, different connectors are available for other implants including a lag screw. See details on the ordering information page. 4 Finish assembly of the lag screw extraction device by tightening the nut 4 and attaching the T-handle 5 in a final step as shown in the picture. Handle Spanner 17mm standard 5 6 12 The lag screw is extracted by counterclockwise rotation and pulling 6 . Use the 7mm spanner wrench if higher forces are required for the removal of the lag screw. Implant Extraction Set Intramedullary Nails Caution: Special care must be taken to check if the nail moves off-center from the entry point when screws are removed. Any attempt to remove a nail that is off-center may result in fractures of the distal condylar region. Conical Extraction Rod Universal Rod Strike Plate The end cap, if used, is removed using a screwdriver. If bone ingrowth obstructs access to the nail, use of either a crown drill, pick (not supplied), or curette (not supplied) may provide access. Sliding Hammer Slotted Hammer Universal Rod Sliding Hammer or use the Slotted Hammer Remove the distal/proximal screw with the appropriate screwdriver bit. Do not take out the screws of the driving (proximal) end until the conical extraction rod is attached to the top of the nail in order to avoid rotation. Insert the conical extraction rod into the driving end of the nail. Lightly hammer the conical extractor in order to fully engage the cutting flutes. Connect the strike plate and the universal rod either adding the sliding or slotted hammer as shown in the picture. Strike Plate Remove the remaining locking screws and confirm with fluoroscopy that locking screws have been removed before using either hammer to remove the nail. Conical Extraction Rod Step 1 Step 2 13 Nails When removing an Intramedullary nail, it is helpful to identify the nail brand and its diameter in order to choose the correct instrumentation. Implant Extraction Set Broken Intramedullary Nails Removal of broken intramedullary nails may be particularly challenging. Stryker developed a system that can be used for the removal of many cannulated intramedullary nails. An incision is made over the proximal end of the nail. The end cap, if used, is removed using a screwdriver. If bone ingrowth obstructs the access to the nail, the use of either a chisel/pick (not provided) or a crown drill will facilitate removal. Conical Extraction Rod Universal Rod Remove the distal screw with the appropriate screwdriver bit. Do not take out the proximal screws until you have attached the conical extraction rod to the top of the nail in order to avoid rotation. Sliding Hammer Connect the universal rod and the strike plate to the extraction rod (center of page) either adding the sliding or the slotted hammer. Strike Plate Extraction Hook Step 1: Insert the nail extraction device into the proximal end of the nail, tightening it as firm as possible. Universal Rod Nails Sliding Hammer Step 2: Remove the proximal screws before using either hammer to remove the nail. Step 3: After removal of the proximal nail end, exchange the conical extraction rod for the extraction hook (as shown to the left). Insert extraction hook into the cannulation of the nail fragment. Under fluoroscopy, verify that the hook has passed through the nail end. Make sure that the hook takes a hold at the end of the nail before pulling to remove it. Strike Plate Step 4: Use the sliding or the slotted hammer to pull out the remaining part of the nail. Extraction Hook Broken Intramedullary Nails - Step 1 Broken Intramedullary Nails - Step 2 14 Broken Intramedullary Nails - Step 3 Broken Intramedullary Nails - Step 4 Notes 15 Manufactured by: Stryker Trauma GmbH Prof.-Küntscher-Straße 1–5 D - 24232 Schönkirchen, Germany 0123 This document is intended solely for the use of healthcare professionals. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate a Stryker product. A surgeon must always refer to the package insert, product label and/or instructions for use, including the instructions for Cleaning and Sterilization (if applicable), before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Stryker. All other trademarks are trademarks of their respective owners or holders. The above listed products are CE marked. Content ID: IES-ST-1 Rev. 2 , 06-2015 (Former Literature Number: B1000057 & LIES-OT) Copyright © 2015 Stryker www.stryker.com